Alzheimer DiseaseNCT03770182

Brain Stimulation for Neurological Patients

A study testing NEUROLITH in people with Alzheimer Disease, run by Storz Medical AG at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective double-blind randomized placebo-controlled crossover clinical trial Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alzheimer Disease
What is being tested?: NEUROLITH
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteAustria
Study dates: 1 Jan 2017to 27 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
At least 3 months of stable antidementive therapy or no antidementive therapy necessary
Signed written informed consent
Monthly pregnancy test for women in childbearing years
Age >= 18 years

Who cannot join

Non-compliance with the protocol
Pregnant or breastfeeding women
Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
Hemophilia or other blood clotting disorders
Cortisone treatment within the last 6 weeks before first treatment
Thrombosis

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna

Other trials in Austria

About this study

This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Conditions: Alzheimer Disease
Being tested: NEUROLITH
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NEUROLITHDevice
Also called transcranial pulse stimulation, TPS
transcranial pulse stimulation (TPS)

Study groups in NCT03770182
Study group	Role	What they receive
Group A	Experimental	NEUROLITH * Cycle 1: Active treatment * Cycle 2: Sham treatment Receives: Device: NEUROLITH
Group B	Experimental	NEUROLITH * Cycle 1: Sham treatment * Cycle 2: Active treatment Receives: Device: NEUROLITH

What is being measured

The primary outcome is the main question the study is designed to answer.

Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score
CERAD stands for "The Consortium to Establish a Registry for Alzheimer's Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013).
The CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Measured: month 3

Secondary outcomes (41)

Alzheimer's Disease Assessment Scale (ADAS)
Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
Measured: immediately post-treatment
Alzheimer's Disease Assessment Scale (ADAS)
Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
Measured: month 1
Alzheimer's Disease Assessment Scale (ADAS)
Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
Measured: month 3
Neuropsychological Test Battery Vienna (NTBV)
The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer's Disease (Lehrner 2007).
Measured: immediately post-treatment
Neuropsychological Test Battery Vienna (NTBV)
Cognitive test
Measured: month 1
Neuropsychological Test Battery Vienna (NTBV)
Cognitive test
Measured: month 3
CERAD
Cognitive test
Measured: immediately post-treatment
CERAD
Cognitive test
Measured: month 1
CERAD
Cognitive test
Measured: month 3
Clock drawing test
The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
Measured: immediately post-treatment
Clock drawing test
Clock drawing test
Measured: month 1
Clock drawing test
Clock drawing test
Measured: month 3
Forgetfulness assessment inventory (FAI)
FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
Measured: immediately post-treatment
Forgetfulness assessment inventory (FAI)
FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
Measured: month 1
Forgetfulness assessment inventory (FAI)
FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
Measured: month 3
Instrumental Activities of Daily Living Scale (IADL) - Patient
IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
Measured: immediately post-treatment
IADL- Patient
IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
Measured: month 1
IADL- Patient
IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
Measured: month 3
Beck Depression Inventory (BDI)
BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Measured: immediately post-treatment
Beck Depression Inventory (BDI)
BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Measured: month 1
Beck Depression Inventory (BDI)
BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Measured: month 3
Prosopagnosia index (PI20)
PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
Measured: immediately post-treatment
Prosopagnosia index (PI20)
PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
Measured: month 1
Prosopagnosia index (PI20)
PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
Measured: month 3
Neuropsychiatric Inventory (NPI) (Care Taker)
The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
Measured: immediately post-treatment
Neuropsychiatric Inventory (NPI) (Care Taker)
The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
Measured: month 1
Neuropsychiatric Inventory (NPI) (Care Taker)
The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
Measured: month 3
IADL (Care Taker)
Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
Measured: immediately post-treatment
IADL (Care Taker)
Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
Measured: month 1
IADL (Care Taker)
Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
Measured: month 3
Bayer Activities of Daily Living Scale (B-ADL)
The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
Measured: [ Time Frame: immediately post-treatment ]
Bayer Activities of Daily Living Scale (B-ADL)
The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
Measured: [ Time Frame: month 1 ]
Bayer Activities of Daily Living Scale (B-ADL)
The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
Measured: [ Time Frame: month 3 ]
Geriatric Depression Scale - short form (GDS-15)
The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Measured: [ Time Frame: immediately post-treatment ]
Geriatric Depression Scale - short form (GDS-15)
The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Measured: [ Time Frame: month 1 ]
Geriatric Depression Scale - short form (GDS-15)
The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Measured: [ Time Frame: month 3 ]
Leisure Behavior (FZV; German: Freizeitverhalten)
The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
Measured: [ Time Frame: immediately post-treatment ]
Leisure Behavior (FZV; German: Freizeitverhalten)
The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
Measured: [ Time Frame: month 1 ]
Leisure Behavior (FZV; German: Freizeitverhalten)
The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
Measured: [ Time Frame: month 3 ]
anatomical Magnetic Resonance Imaging (MRI)
3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain.
Measured: immediately post-treatment
functional Magnetic Resonance Imaging (fMRI)
3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001.
Measured: immediately post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201727 Jul 2022

First posted10 Dec 2018
Study start1 Jan 2017
Primary completion27 Jul 2022
Study completion27 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03770182
Sponsor's protocol ID: TPS-AD-Vienna
Status last verified: Nov 2023
First submitted: 7 Sep 2018
Last updated: 22 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chandler MJ, Lacritz LH, Hynan LS, Barnard HD, Allen G, Deschner M, Weiner MF, Cullum CM. A total score for the CERAD neuropsychological battery. Neurology. 2005 Jul 12;65(1):102-6. doi: 10.1212/01.wnl.0000167607.63000.38.
PubMed 16009893
Fillenbaum GG, van Belle G, Morris JC, Mohs RC, Mirra SS, Davis PC, Tariot PN, Silverman JM, Clark CM, Welsh-Bohmer KA, Heyman A. Consortium to Establish a Registry for Alzheimer's Disease (CERAD): the first twenty years. Alzheimers Dement. 2008 Mar;4(2):96-109. doi: 10.1016/j.jalz.2007.08.005.
PubMed 18631955
Hallikainen I, Hanninen T, Fraunberg M, Hongisto K, Valimaki T, Hiltunen A, Karppi P, Sivenius J, Soininen H, Koivisto AM; ALSOVA study group. Progression of Alzheimer's disease during a three-year follow-up using the CERAD-NB total score: Kuopio ALSOVA study. Int Psychogeriatr. 2013 Aug;25(8):1335-44. doi: 10.1017/S1041610213000653. Epub 2013 May 16.
PubMed 23676340
Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
PubMed 6496779
Morris JC, Mohs RC, Rogers H, Fillenbaum G, Heyman A. Consortium to establish a registry for Alzheimer's disease (CERAD) clinical and neuropsychological assessment of Alzheimer's disease. Psychopharmacol Bull. 1988;24(4):641-52. No abstract available.
PubMed 3249766
Ehrensperger MM, Berres M, Taylor KI, Monsch AU. Early detection of Alzheimer's disease with a total score of the German CERAD. J Int Neuropsychol Soc. 2010 Sep;16(5):910-20. doi: 10.1017/S1355617710000822. Epub 2010 Aug 4.
PubMed 20682088
Rossetti HC, Munro Cullum C, Hynan LS, Lacritz LH. The CERAD Neuropsychologic Battery Total Score and the progression of Alzheimer disease. Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):138-42. doi: 10.1097/WAD.0b013e3181b76415.
PubMed 20505431
Seo EH, Lee DY, Lee JH, Choo IH, Kim JW, Kim SG, Park SY, Shin JH, Do YJ, Yoon JC, Jhoo JH, Kim KW, Woo JI. Total scores of the CERAD neuropsychological assessment battery: validation for mild cognitive impairment and dementia patients with diverse etiologies. Am J Geriatr Psychiatry. 2010 Sep;18(9):801-9. doi: 10.1097/JGP.0b013e3181cab764.
PubMed 20220577
Irizarry MC, Webb DJ, Bains C, Barrett SJ, Lai RY, Laroche JP, Hosford D, Maher-Edwards G, Weil JG. Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease. J Alzheimers Dis. 2008 Jul;14(3):301-11. doi: 10.3233/jad-2008-14304.
PubMed 18599956
Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease scales: is there a need for a new multi-domain scale for therapy evaluation in medical practice? Alzheimers Res Ther. 2010 Aug 26;2(4):24. doi: 10.1186/alzrt48.
PubMed 20796301
Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
Shulman, K. I.; Shedletsky, R. & Silver, I. L.The challenge of time: Clock-drawing and cognitive function in the elderly. International journal of geriatric psychiatry, Wiley Online Library 1: 135-140, 1986.
Kogler, B. Subjective Memory Complaint in Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease. Vienna: University of Vienna, 2013
Lehrner J, Moser D, Klug S, Gleiss A, Auff E, Dal-Bianco P, Pusswald G. Subjective memory complaints, depressive symptoms and cognition in patients attending a memory outpatient clinic. Int Psychogeriatr. 2014 Mar;26(3):463-73. doi: 10.1017/S1041610213002263. Epub 2013 Dec 5.
PubMed 24308705
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PubMed 5349366

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Stimulation for Neurological Patients
ClinicalTrials.gov ID: NCT03770182
Acronym / sponsor ID: TPS-AD-Vienna
Conditions: Alzheimer Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Storz Medical AGIndustry (pharma, biotech, devices)
Collaborators: Medical University of Vienna
Study start: 1 Jan 2017 (actual)
Primary completion: 27 Jul 2022 (actual)
Study completion: 27 Jul 2022 (actual)
First posted: 10 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Device: NEUROLITHNEUROLITH * Cycle 1: Active treatment * Cycle 2: Sham treatment
Group B	Experimental	Device: NEUROLITHNEUROLITH * Cycle 1: Sham treatment * Cycle 2: Active treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
At least 3 months of stable antidementive therapy or no antidementive therapy necessary
Signed written informed consent
Monthly pregnancy test for women in childbearing years
Age >= 18 years

Key exclusion criteria (6 listed)

Non-compliance with the protocol
Pregnant or breastfeeding women
Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
Hemophilia or other blood clotting disorders
Cortisone treatment within the last 6 weeks before first treatment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NEUROLITHAlso: transcranial pulse stimulation, TPStranscranial pulse stimulation (TPS)	Device	Group A, Group B

Primary outcome

Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score
Time frame: month 3
CERAD stands for "The Consortium to Establish a Registry for Alzheimer's Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013). The CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".

41 secondary outcomes

Alzheimer's Disease Assessment Scale (ADAS)
Time frame: immediately post-treatment
Alzheimer's Disease Assessment Scale (ADAS)
Time frame: month 1
Alzheimer's Disease Assessment Scale (ADAS)
Time frame: month 3
Neuropsychological Test Battery Vienna (NTBV)
Time frame: immediately post-treatment
Neuropsychological Test Battery Vienna (NTBV)
Time frame: month 1
Neuropsychological Test Battery Vienna (NTBV)
Time frame: month 3
CERAD
Time frame: immediately post-treatment
CERAD
Time frame: month 1
CERAD
Time frame: month 3
Clock drawing test
Time frame: immediately post-treatment
Clock drawing test
Time frame: month 1
Clock drawing test
Time frame: month 3
Forgetfulness assessment inventory (FAI)
Time frame: immediately post-treatment
Forgetfulness assessment inventory (FAI)
Time frame: month 1
Forgetfulness assessment inventory (FAI)
Time frame: month 3
Instrumental Activities of Daily Living Scale (IADL) - Patient
Time frame: immediately post-treatment
IADL- Patient
Time frame: month 1
IADL- Patient
Time frame: month 3
Beck Depression Inventory (BDI)
Time frame: immediately post-treatment
Beck Depression Inventory (BDI)
Time frame: month 1
Beck Depression Inventory (BDI)
Time frame: month 3
Prosopagnosia index (PI20)
Time frame: immediately post-treatment
Prosopagnosia index (PI20)
Time frame: month 1
Prosopagnosia index (PI20)
Time frame: month 3
Neuropsychiatric Inventory (NPI) (Care Taker)
Time frame: immediately post-treatment
Neuropsychiatric Inventory (NPI) (Care Taker)
Time frame: month 1
Neuropsychiatric Inventory (NPI) (Care Taker)
Time frame: month 3
IADL (Care Taker)
Time frame: immediately post-treatment
IADL (Care Taker)
Time frame: month 1
IADL (Care Taker)
Time frame: month 3
Bayer Activities of Daily Living Scale (B-ADL)
Time frame: [ Time Frame: immediately post-treatment ]
Bayer Activities of Daily Living Scale (B-ADL)
Time frame: [ Time Frame: month 1 ]
Bayer Activities of Daily Living Scale (B-ADL)
Time frame: [ Time Frame: month 3 ]
Geriatric Depression Scale - short form (GDS-15)
Time frame: [ Time Frame: immediately post-treatment ]
Geriatric Depression Scale - short form (GDS-15)
Time frame: [ Time Frame: month 1 ]
Geriatric Depression Scale - short form (GDS-15)
Time frame: [ Time Frame: month 3 ]
Leisure Behavior (FZV; German: Freizeitverhalten)
Time frame: [ Time Frame: immediately post-treatment ]
Leisure Behavior (FZV; German: Freizeitverhalten)
Time frame: [ Time Frame: month 1 ]
Leisure Behavior (FZV; German: Freizeitverhalten)
Time frame: [ Time Frame: month 3 ]
anatomical Magnetic Resonance Imaging (MRI)
Time frame: immediately post-treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Background: PubMed 16009893Chandler MJ, Lacritz LH, Hynan LS, Barnard HD, Allen G, Deschner M, Weiner MF, Cullum CM. A total score for the CERAD neuropsychological battery. Neurology. 2005 Jul 12;65(1):102-6. doi: 10.1212/01.wnl.0000167607.63000.38.
Background: PubMed 18631955Fillenbaum GG, van Belle G, Morris JC, Mohs RC, Mirra SS, Davis PC, Tariot PN, Silverman JM, Clark CM, Welsh-Bohmer KA, Heyman A. Consortium to Establish a Registry for Alzheimer's Disease (CERAD): the first twenty years. Alzheimers Dement. 2008 Mar;4(2):96-109. doi: 10.1016/j.jalz.2007.08.005.
Background: PubMed 23676340Hallikainen I, Hanninen T, Fraunberg M, Hongisto K, Valimaki T, Hiltunen A, Karppi P, Sivenius J, Soininen H, Koivisto AM; ALSOVA study group. Progression of Alzheimer's disease during a three-year follow-up using the CERAD-NB total score: Kuopio ALSOVA study. Int Psychogeriatr. 2013 Aug;25(8):1335-44. doi: 10.1017/S1041610213000653. Epub 2013 May 16.
Background: PubMed 6496779Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
Background: PubMed 3249766Morris JC, Mohs RC, Rogers H, Fillenbaum G, Heyman A. Consortium to establish a registry for Alzheimer's disease (CERAD) clinical and neuropsychological assessment of Alzheimer's disease. Psychopharmacol Bull. 1988;24(4):641-52. No abstract available.
Background: PubMed 20682088Ehrensperger MM, Berres M, Taylor KI, Monsch AU. Early detection of Alzheimer's disease with a total score of the German CERAD. J Int Neuropsychol Soc. 2010 Sep;16(5):910-20. doi: 10.1017/S1355617710000822. Epub 2010 Aug 4.
Background: PubMed 20505431Rossetti HC, Munro Cullum C, Hynan LS, Lacritz LH. The CERAD Neuropsychologic Battery Total Score and the progression of Alzheimer disease. Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):138-42. doi: 10.1097/WAD.0b013e3181b76415.
Background: PubMed 20220577Seo EH, Lee DY, Lee JH, Choo IH, Kim JW, Kim SG, Park SY, Shin JH, Do YJ, Yoon JC, Jhoo JH, Kim KW, Woo JI. Total scores of the CERAD neuropsychological assessment battery: validation for mild cognitive impairment and dementia patients with diverse etiologies. Am J Geriatr Psychiatry. 2010 Sep;18(9):801-9. doi: 10.1097/JGP.0b013e3181cab764.
Background: PubMed 18599956Irizarry MC, Webb DJ, Bains C, Barrett SJ, Lai RY, Laroche JP, Hosford D, Maher-Edwards G, Weil JG. Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease. J Alzheimers Dis. 2008 Jul;14(3):301-11. doi: 10.3233/jad-2008-14304.
Background: PubMed 20796301Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease scales: is there a need for a new multi-domain scale for therapy evaluation in medical practice? Alzheimers Res Ther. 2010 Aug 26;2(4):24. doi: 10.1186/alzrt48.
BackgroundLehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
BackgroundShulman, K. I.; Shedletsky, R. & Silver, I. L.The challenge of time: Clock-drawing and cognitive function in the elderly. International journal of geriatric psychiatry, Wiley Online Library 1: 135-140, 1986.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roland Beisteiner, Prof. principal investigator

Medical University of Vienna

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NEUROLITH in people with Alzheimer Disease, run by Storz Medical AG at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score (time frame: month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03770182, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.